Dispensing device

ABSTRACT

A dispenser includes a dispenser housing, an indicating device connected to the dispenser housing and a container removably engaged with the dispenser housing. The container and the dispenser housing remain connected as the container is moved between an engaged position and a disengaged position relative to the dispenser housing. The dispenser housing includes an upper portion pivotally connected to a lower portion.

This application is a continuation of U.S. application Ser. No.13/414,411, filed Mar. 7, 2012, which is a continuation of U.S.application Ser. No. 11/888,308, filed Jul. 31, 2007, which applicationclaims the benefit of U.S. Provisional Application No. 60/834,764, filedAug. 1, 2006, the entire disclosures of which are hereby incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates generally to a dispensing device, and inparticular, to a dispensing device having a dosage indicator forindicating the number of metered dosages that have been dispensed from,or remain in, a container that is associated with that particulardispensing device.

BACKGROUND

Aerosol dispensing devices have been developed that include a doseindicating device to indicate the number of metered doses that have beendispensed from the device, or to indicate the number of doses remainingtherein. For example, patients have certain conditions that can betreated with medicaments dispensed in an aerosol and administered to thepatient by inhalation. In one format, the aerosol with medicaments arecontained in a container, and dispensed in metered, or measured, dosageswith an inhalation device, or actuator boot. In such an arrangement, itcan be important for the patient to be able to ascertain the number ofmetered doses remaining in the container, either by an indication of thenumber remaining therein or by knowledge of the number already dispensedtherefrom, such that the patient is not caught unaware with an emptycontainer when in need of the medicament. Thus, it may be important forthe inhalation device to provide an accurate indication of either thenumber of doses remaining in the container, or the number of dosesalready dispensed therefrom.

In some embodiments, for example metered dose inhalers configured withcontainers holding HFA propellant, the actuator nozzle or well may needto be cleaned periodically to ensure proper aerosol drug delivery andoutput. In conventional embodiments, the container is simply removedfrom the actuator and water is used to clear the actuator nozzle.However, when the dispensing device is configured with an indicatordevice, for example a device located in the actuator boot, there ispotential for a different container to be associated with the actuatorboot and indicator device, thereby leading to an inaccurate count ofdosages dispensed from or remaining in that container.

SUMMARY

Briefly stated, in one aspect the invention is directed to a dispenserthat dispenses dosages of a substance. The dispenser includes acontainer having an end portion and a valve stem extending from the endportion. A dispenser housing includes a nozzle having a well. Anindicating device is connected to the dispenser housing and includes anindicator with dosage indicia. The container is moveable between anengaged position, wherein the valve stem is disposed in the well and adisengaged position, wherein the valve stem is removed from the well. Inthe disengaged position, the actuator nozzle is accessible for cleaningwithout getting water on the valve stem. A connection is maintainedbetween the container and the dispenser housing, however, such that thesame container is associated with the dispenser housing and indicatingdevice thereby maintaining the count integrity of the device.

In one embodiment, the dispenser housing includes an upper portionpivotally connected to a lower portion. The indicating device isconnected to the lower portion, while the container is moveablyconnected to the upper portion. The upper and lower portions arepivotable between at least a first and second position.

In one embodiment, the upper portion is pivotal relative to the lowerportion about a longitudinal axis. In another embodiment, the upperportion is pivotal relative to the lower portion about an axisnon-parallel to the longitudinal axis, and preferably about an axissubstantially perpendicular to the longitudinal axis.

In one embodiment, a locking collar maintains a fixed connection of theupper and lower portions when the container is engaged with the supportblock. The locking collar is moveable so as to disengage the containerfrom the support block and unlock or release the upper portion from thelower portion, such that the upper portion, with the container coupledthereto, can be pivoted relative to the lower portion.

In yet another aspect, a method for dispensing dosages from thecontainer and for disengaging the container from the support block whilemaintaining a connection with the dispenser housing is provided.

The various embodiments provide simple, robust and inexpensive solutionsfor providing the user with information allowing them to ascertain thenumber of metered doses remaining in the container, either by anindication of the number remaining therein or by knowledge of the numberalready dispensed therefrom. In addition, the container remainsconnected to the dispenser housing, even if it is disengaged from thesupport block, for example to clean the housing, thereby ensuring thatthe integrity of the dose count for the container is preserved and alsothat the container will be used with a properly configured dispenserhousing. In the latter situation, it should be understood that thedispenser housing and container can be used without an indicatingdevice.

The foregoing paragraphs have been provided by way of generalintroduction, and are not intended to limit the scope of the followingclaims. The various preferred embodiments, together with furtheradvantages, will be best understood by reference to the followingdetailed description taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an exploded perspective view of a first embodiment of adispensing device.

FIG. 1B is an assembled perspective view of the dispensing device shownin FIG. 1A.

FIG. 2 is a front view of the dispensing device shown in FIG. 1B.

FIG. 3 is partial cross-sectional view of the dispensing device shown inFIG. 2 taken along line 3-3.

FIG. 4 is a side view of the dispensing device shown in FIG. 1B.

FIG. 5 is a rear view of the dispensing device shown in FIG. 1B.

FIG. 6 is a top view of the dispensing device shown in FIG. 1B.

FIG. 7 is a bottom view of the dispensing device shown in FIG. 1B.

FIGS. 8A-8E are side views of the dispensing device shown in FIG. 1B asthe device is moved from a ready-to-use configuration to aready-to-clean configuration.

FIG. 9 is a first side view of an upper portion of the dispenserhousing.

FIG. 10 is a cross-sectional view of the upper portion shown in FIG. 9taken along line 10-10.

FIG. 11 is a second side view of the upper portion.

FIG. 12 is a top view of the upper portion.

FIG. 13 is a side view of a connector member.

FIG. 14 is a cross-sectional view of the connector member shown in FIG.13 taken along line 14-14.

FIG. 15 is another side view of the connector member.

FIG. 16 is a perspective view of the connector.

FIG. 17 is a top view of the connector.

FIG. 18 is a perspective view of a lower portion of the dispenserhousing.

FIG. 19 is a top view of the lower portion.

FIG. 20 is a cross-sectional view of the lower portion shown in FIG. 19taken along line 20-20.

FIG. 21 is a front view of the lower portion.

FIG. 22 is a side view of the lower portion.

FIG. 23 is a rear view of the lower portion.

FIG. 24 is a perspective view of a retainer member.

FIG. 25 is a top view of the retainer member.

FIG. 26 is a cross-sectional view of the retainer member taken alongline 26-26 of FIG. 25.

FIG. 27 is a first side view of the retainer member.

FIG. 28 is a second side view of the retainer member.

FIG. 29 is an exploded perspective view of a second embodiment of adispensing device.

FIG. 30 is a front view of the dispensing device shown in FIG. 29.

FIG. 31 is a partial cross-sectional view of the dispensing device shownin FIG. 30 taken along line 31-31.

FIG. 32 is a side view of the dispensing device shown in FIG. 29.

FIG. 33 is a rear view of the dispensing device shown in FIG. 29.

FIG. 34 is a bottom view of the dispensing device shown in FIG. 29.

FIG. 35 is a top view of the dispensing device shown in FIG. 29.

FIG. 36 is a perspective view of the assembled dispensing device shownin FIG. 29.

FIGS. 37A-37D are side views of the dispensing device shown in FIG. 36as the device is moved from a ready-to-use configuration to aready-to-clean configuration.

FIG. 38 is a perspective view of a lower portion of dispenser housing.

FIG. 39 is a top view of the lower portion.

FIG. 40 is a cross-sectional view of the lower portion shown in FIG. 39taken along line 40-40.

FIG. 41 is a front view of the lower portion.

FIG. 42 is a side view of the lower portion.

FIG. 43 is a rear view of the lower portion.

FIG. 44 is a perspective view of a retainer member.

FIG. 45 a top view of the retainer member.

FIG. 46 is a cross-sectional view of the retainer member taken alongline 46-46 of FIG. 45.

FIG. 47 is a first side view of the retainer member.

FIG. 48 is a second side view of the retainer member.

FIG. 49 is a top view of the upper portion of the dispenser housing.

FIG. 50 is a side view of the upper portion.

FIG. 51 is a cross-sectional view of the upper portion shown in FIG. 50taken along line 51-51.

FIG. 52 is another side view of the upper portion.

FIG. 53 is a cross-sectional view of the upper portion shown in FIG. 52taken along line 53-53.

FIGS. 54A and 54B show an assembled and exploded view of a firstindicator assembly.

FIGS. 55A and 55B show an assembled and exploded view of a secondindicator assembly.

FIGS. 56A and 56B show an assembled and exploded view of a thirdindicator assembly.

FIG. 57 shows an exploded view of the first embodiment of the dispensingdevice.

FIG. 58 shows a partial cross-sectional view of the indicating deviceshown in FIG. 57.

FIG. 59A is a bottom perspective view of a dispensing device in aready-for-use position.

FIG. 59B shows the dispensing device of FIG. 59A moved between theready-for-use and cleaning positions.

FIG. 59C shows the dispensing device of FIG. 59A in a cleaning position.

FIG. 60 is an exploded perspective view of another embodiment of thedispensing device.

FIG. 61A is a perspective view of one embodiment of the dispensingdevice having an open configuration locking/connector member.

FIG. 61B is a perspective view of another embodiment of the dispensingdevice having a closed configuration locking/connector member.

FIG. 62A is a top perspective view of one embodiment of a retainermember.

FIG. 62B is a bottom perspective view of the retainer member shown inFIG. 62A.

FIG. 63A is a bottom perspective view of one embodiment of alocking/connector member.

FIG. 63B is a bottom view of the locking/connector member shown in FIG.63A.

FIG. 64 is a perspective view of one embodiment of a lower portion of anactuator boot/housing.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

Referring to the drawings, and in particular FIGS. 1-8E and 57-62B, adispensing device, or dispenser, is shown as including a housing 10, 310or actuator boot, and a container 100 disposed therein. In a firstembodiment, the actuator boot has an upper cylindrical portion 12, 312,referred to as a chimney, and a lower portion 14, 314.

Referring to FIGS. 1A, 18-23 and 64, the lower portion 14, 314 isconfigured with a mouthpiece 16, 316 and includes a support block 18having a well for receiving the valve stem 102 of the container and acavity 20 for receiving an indicating device 50. An orifice penetratesthe support block 18, to communicate with a bottom portion of the well.The mouthpiece 16, 316 intended for insertion into the mouth of apatient, forms an exhaust port that communicates with the orifice andwell. The mouthpiece 16, 316 extends laterally from the housing so as tofacilitate insertion of the mouthpiece into the mouth of the patient.

A hinge post 22, 322, or pin, extends upwardly from the lower portionpast an upper circumferential rim 24, 324 thereof. The hinge pinincludes a head 26, 326 formed at an end thereof that functions as astop device.

The lower portion further includes a pair of guides or locator pins 28,328, otherwise referred to as followers, extending radially outwardlyfrom opposite sides of the lower portion adjacent the uppercircumferential rim. It should be understood that a single lug or guide28, 328 may suffice, or that more than two guides may be suitable forsecuring the lower portion to a connector member 80, 380, as shown inFIGS. 1A-8E and 59A-61B. As further discussed below, the indicatingdevice 50 is removably or fixedly disposed in the lower portion. Forexample, as shown in FIGS. 61A and 64, an opening is formed in the lowerportion

Referring to FIGS. 1A, 9-12, 57 and 60-61B, the upper portion 12, 312 isopen at both ends and includes a pair of longitudinally extending slots30, 330 formed through a side wall 32, 332 thereof that are shaped andconfigured to engage a pair of lugs 92, 292, 392 or followers, formed ona retainer member 90, 290, 390 shown in FIGS. 24-28, 57 and 60. Theupper portion 12, 312 further includes a pair of lugs, orguides/followers 34, 334, extending radially outwardly from the lowerportion adjacent a lower circumferential rim 36, 336 thereof. The lugs34, 334 are shaped to mate with the lugs 28 formed on the lower portion,with the lugs preferably being mirror images of each other, such thatthe lugs 28, 328, 34, 334 in combination form a guide. Accordingly, thenumber of lugs 34, 334 on the upper portion preferably matches thenumber of lugs 28, 328 on the lower portion, and further are spaced andconfigured to mate with the lugs 28, 328 on the lower portion. Ofcourse, it should be understood that other configurations are suitable.

The upper portion 12, 312 further includes a longitudinally extendingtube or shroud 38, 338 defining a longitudinally extending opening orchannel 40, 340 shaped to receive the hinge pin 22, 322. The hinge pinis disposed in the channel 40, 340 with the head engaging a bottomshoulder or rim formed in the shroud to fix the lower and upper portions14, 314, 12, 312 together, but allow rotational and longitudinalmovement therebetween. In this way, the hinge pin and shroud, or socket,act as a connector between the upper and lower portions. The containeris inserted through the upper portion of the housing with a bottom end102 of the container protruding from the upper portion and exposed tothe user for actuation.

Referring to FIGS. 1A, 13-17, 57, 60 and 63A-B, the connector member 80,380 otherwise referred to as a locking collar/member, includes agenerally cylindrically shaped tube 82, 382 having an enlarged portion84, 384 formed on one side thereof. The enlarged portion forms aninterior cavity 86, 386 relative to a cylindrical boundary formed by theinterior surface of the tube 82, 382. The upper and lower portions 12,312, 14, 314 have an outer cylindrically shaped surface that isdimensioned to be received inside the tube portion 82, 382 of theconnector member. An upper lip portion 24, 324 of the lower portionforms a friction fit with a bottom lip or rim 36, 336 of the upperportion (or vice versa) such that the upper and lower portions arereleasably joined. The connector member maintains a connection betweenthe upper and lower portions when in a locked position. The term“connected,” or variations thereof, as used herein means that two ormore members or components are coupled, whether directly or indirectly,for example with an intervening member or component. For example, itshould be understood that the container is connected to the dispenserhousing when it is connected to the indicator assembly, which in turn isconnected to the dispenser housing. The term “fixedly connected,” orvariations thereof, means that one component connected to another is notmeant to be disconnected during the normal operation of the device andwithout undue force, while “releasably connected,” means that onecomponent is meant to be disconnected during such normal operation andwithout undue force.

When the upper and lower portions are joined, the half-lugs 28, 328, 34,334 form one or more guides that are disposed in a pair of horizontallyor laterally, circumferentially formed slots 88, 388 formed in theconnector member. The guides follow in the tracks defined by the slots88, 388 to maintain the upper and lower portions in a locked position orconfiguration. A release opening 42, 342 is formed at one end of theslot 88 such that the slot 88 opens downwardly through the rim of theconnector member. The slots can be numbered so as to correspond to thenumber of guides formed on the upper and lower portions. In theembodiment shown in FIGS. 60 and 63A-B, an annular rim portion extendsaround the lower perimeter of the connector member 388, with the opening342 formed by a recess located interiorly of an our portion of the rim343, as shown in FIGS. 63A-B.

The connector member further includes a pair of disengagement slots 44,344 formed on opposite sides thereof. The slots are each configured witha ramped portion, extending both longitudinally and laterally around thelocking collar 80, 380, and terminating at opposite ends in enlargedportions 46, 346, and longitudinally extending slot 48, 348. In oneembodiment, the enlarged portions 46, 346 are configured as an upwardly,longitudinally extending slot, while the lower slot 48, 348 extendsdownwardly. The openings 44, 344, 46, 346, 48, 348 are shaped anddimensioned to receive the lugs 92, 292, 392 or followers of theretainer member, shown in FIGS. 1A, 57, 60 and 62A-B. The slots can benumbered so as to correspond to the number of lugs on the retainermember and the corresponding number of longitudinally extending slotsformed on the upper member, i.e., one or more.

In one embodiment (see e.g., FIG. 15), the upper portion 46 is forms asmall recess slot, or enlarged opening, while in another embodiment(see, e.g., FIGS. 8A-8E), the slot 46 extends vertically upwardly. Thelonger slot of FIGS. 8A-8E allow for the container to be furtherretracted into the cavity formed by the locking collar such that thevalve stem is not exposed below the lower rim of the locking collar.

Referring to FIGS. 63A-B, the connector/locking member 380 includes alocking member, or stop member 402, which extends radially inwardly froman interior of the enlarged portion 384 into the cavity 386, along abottom edge portion of the enlarged portion.

Referring to FIG. 61B, the top of the locking collar 480, and inparticular enlarged portion 484, can be closed, so as to improve theaesthetics of the device, as well as to help reduce the likelihood oftampering and/or contamination. Likewise, the openings 388, 344, 346,348 and 342 (see FIG. 61A) can all be formed on an interior surface ofthe collar 480. As such, it should be understood that the term“opening,” “slot,” etc., includes but does not require penetrationthrough the entire thickness of a component, but rather is meant toinclude an undercut or recess formed in such a component. A bottomportion 418 of the lower portion 414 also can be curved so as to varythe aesthetics of the device.

Referring to FIGS. 1A, 24-28, 57, 60, 62A-B, the retainer member 92,292, 392 includes a ring 94 or a collar 294, 394, a pair of flanges 96,396 or supports extending longitudinally from the ring and a lug or pin92, 292, 392, otherwise referred to as an engaging portion or follower,extending radially outward from each flange 96, 396, or as shown in FIG.57 radially outward form the collar 294. The ring 94 and collar 294 havean inner scalloped rim 98 having a plurality of gripping portions 99configured and dimensioned to engage a neck of the container 100. Thering or collar can be snapped onto the container so as to be fixedlyconnected thereto. The retainer member functions as and provides aconnector member between the container and the dispenser housing.

In the embodiment of FIGS. 62A-B, a plurality of tabs 398 engage thecontainer, for example the ferrule portion thereof, with a snap fit,such that the collar 394 is fixedly connected to the container. Adjacentan opposite end of the collar 394, an annular ring 399, having aplurality of vent openings 397 positioned therein, defines a centralopening through which the valve stem of the container extends. An endportion of the container is disposed between the ring 399 and the tabs398. The diameter of the opening can be varied, for example such thatthe container can directly engage a portion of an indicating device,such as an actuation post 72. Alternatively, the post is engaged by thering 399.

To assemble the device, the retainer 90, 190, 390, 390 is connected tothe container 100. The upper portion 12, 312 is inserted through thelocking collar 80, 380 such that the shroud 38, 338 is received in thecavity of the enlarged portion 84, 384. The lower portion 14, 314 isconnected to the upper portion 12, 312, with the lugs 28, 328, 34, 334mating and disposed through the release opening 42, 342, and into thecircumferential slot 88, 388. The hinge pin 22, 322 is inserted throughthe channel 40, 340 to secure the upper member to the lower member, withthe locking member 80, 380 disposed therearound. The support members 96,396 of the retainer are flexed such that the lugs 92, 392, or guides,can be slid along longitudinally extending tracks 52 formed on aninterior surface of the upper portion and thereafter be snap fittedthrough the longitudinal slots 30, 330 in the upper portion and thedisengagement openings/slots 44, 344, 46, 346, 48, 348 of the connectormember 80, 380.

In operation, and referring to FIGS. 8A-8E, 60 and 61A, the useroperates the container 100 in the normal way, with the indicating device50 providing an indication of the number of doses of medicamentdispensed from or remaining in the container. During this sequence, thelugs 92, 392 of the retainer member simply move longitudinally in thelongitudinal slot 30, 330 of the upper portion and the lowerlongitudinal slot 48, 348 of the disengagement slot formed in thelocking collar. Referring to FIGS. 8A-E and 59A-C, when the supportblock 18, or other portion of the dispenser housing, requires cleaning,the user twists the locking collar member 80, 380 relative to the upperand lower portions 12, 312, 14, 314, or vice versa, with the combinedguides 28, 328, 34, 334 moving within the circumferential slot 88, 388and the shroud 38, 338 moving laterally within the cavity 86, 386 formedby the enlarged portion 84, 384. The shroud can be releasably fixed in afirst, ready-for-use position and a second cleaning position by a pairof detents 54, 354 or protuberances formed on the interior surface ofthe enlarged portion (see, e.g., FIGS. 16, 63A-B), with the shroud heldin one of the ready for use or ready for cleaning positions by thedetents 54, 354. It should be understood that the hinge pin and shroudcan be arranged on the other of the lower and upper portions.

As the connector member 80, 380 is rotated, the followers or lugs 92,392 of the retainer member ride along the ramped portion 44, 344 of theslot, thereby forcing the container 100 upwardly relative to the lowerportion and out of engagement with the support block 18. As the lugs 28,328, 34, 334 are moved from a locked position in the slot 88, 388 to arelease position over the release opening 42, 342, the user then canseparate or move the lower portion from the upper portion in alongitudinal direction. While the guides 28, 328, 34, 334 are moved inthe slot 88, 388, the container 100 and retaining ring 90, 292, 392, andin particular the followers 92, 292, 392, are moved longitudinallyupward within the slots 30, 330, 44, 344 so as to disengage the valvestem from the support block. As the guide 28, 328 is moved through therelease opening 42, 342, the lower portion 14, 314 is separated from theupper portion 12, 312. The lower portion 14, 314 is moved downwardlyuntil the hinge pin head 26, 326 engages a stop portion formed at abottom of the channel 40, 340 in the shroud. The lower portion 14, 314then can be rotated about a longitudinal axis defined by the hinge pin22, 322 so as to expose the support block for cleaning while maintaininga separation of the lower portion from the upper portion and theattached container. The device can be reassembled by following thereverse steps.

In this way, the container is maintained in connection with a specificindicating device such that the count of the device is not corruptedwhile at the same time allowing the container to be cleaned.

In another aspect, the container can be moved to a disengaged position,as shown in FIG. 8C, but with the lower portion and upper portionremaining in an engaged configuration, for example by way of thefriction fit between the lip portion 24 and the rim 36. As such, thecontainer cannot be inadvertently actuated, since the valve stem is notengaged with the support block, for example during transport. At thesame time, the lower portion remains coupled to the upper portion suchthat the valve stem is not exposed. The dispenser housing can also beconfigured with a detent, or an additional slot, that maintains theposition of the container in the disengaged position while the upper andlower portions remain engaged.

In one embodiment, one or both of slot 46, 346 or the upper portion ofslot 30, 330 is tapered or narrowed so as to frictionally engage thefollowers 92 and maintain a disengaged position of the containerrelative to the lower portion and support block such that the containerdoes not inadvertently slide back down the ramped slot 44 and becomeengaged or inadvertently actuated.

Referring to the embodiment shown in FIGS. 59A-C, as the locking collar380 is rotated, the stop or locking member 402 passes beneath a bottomportion of the hinge pin 322. As the upper and lower portions 312, 314are then separated (see, FIG. 59C), the stop member 402 is movedrelative to the pin 322, such that the pin is disposed between thestop/locking member 402 and a shoulder portion of the enlarged portion384. In this way, the stop/locking member 402 engages the pin 322, andprevents rotation of the collar 380 while the device is in the open,cleaning position. This prevents the user from attempting to rotate thecollar 380 while the upper and lower portions 312, 314 are separated orspaced apart in the longitudinal direction.

In another embodiment, shown in FIGS. 29-53, the dispensing deviceincludes a lower, mouthpiece portion 114, an upper, chimney portion 112and a retainer member 190. As described above with respect to the firstembodiment, an indicating device 50 is disposed and secured in the lowerportion 114, which also includes a mouthpiece 16 and support block 18. Alip portion or rim 124 is formed around the upper circumferential rim ofthe lower portion and engages the lower circumferential rim 136 of theupper portion with a friction fit. One of the lower portion and upperportion includes a pair of spaced apart lugs 134, while the other of theupper and lower portions includes a hinge pin 122 secured to the lugs soas to form a pivotable connection between the upper and lower portions.The hinge pin can be formed integrally with one or both of the upper andlower portions, or can be formed as a separate member, and can beengaged with a socket or lugs formed on the other of the upper and lowerportions. The upper and lower portions alternatively can be formedintegrally with a living hinge connecting those portions. The hinge pinforms a connector between the upper and lower portion. The upper portionfurther includes a pair of loops or guides 138 extending radially inwardfrom an interior surface thereof, as shown in FIG. 51.

The retainer 190 includes a pair of elongated arms 196, each having ahook or engaging portion 192 formed at a terminal end thereof. Theretainer also includes a ring portion 194 with a rim 98 and grippingmembers 99 as described above. The retainer functions as and forms aconnector between the container and the dispenser housing.

To assemble the device, the container 100 is connected to the retainer190, and the upper and lower portions are pivotally engaged by way ofthe hinge pin 122. The retainer 190 and container are then inserted withthe arms 196 extending through the guides 138 of the upper portion andwith the engaging portion 192 bottoming out on, or engaging, the guides138 when the container is in a disengaged position. It should beunderstood that the steps of the various installation methods can berearranged as deemed suitable.

In operation, the user pulls the container 100 upwardly in alongitudinally direction until the engagement portions 192 on the endsof the arms engage a lower surface of the guides 138. In this position,the valve stem 102 is disengaged from the support block 18 of the lowerportion. The user then rotates the container and upper portion about thehinge axis relative to the lower portion to expose the support block tothe user for cleaning. The device can be reassembled following thereverse steps.

The term “longitudinal” as used herein is intended to indicate thedirection of the reciprocal movement of the container relative to thehousing. The terms “top,” “bottom,” “upwardly” and “downwardly” areintended to indicate directions when viewing the inhalation devices asshown in the Figures, but with the understanding that the container isinverted such that the top surface thereof is located adjacent thebottom of the housing and vice versa.

The container 100 is formed as a cylindrical canister having a hubdisposed on a top surface thereof. The container also has a shoulder anda neck portion. The valve stem 102 extends longitudinally from the hub.The valve stem extends coaxially from the canister and is biasedoutwardly therefrom by a spring (not shown) mounted within the canister.The container 100 is mounted in the dispenser housing by press fittingthe valve stem in the well of the support block 18, which defines an“engaged” position of the container. The container is in a “disengaged”position when the valve stem 102 is removed from the well of the supportblock 18.

It should be understood that the container can be configured in avariety of shapes and sizes, and that the substance contained thereincan be released by any number of valve systems that are well known inthe art. It should also be understood that the valve system can beactuated by a variety of actuators, including, but not limited to,various pumps, levers, actuator boots, buttons and the like. In suchembodiments, the valve system can be actuated by an actuator moveablerelative to the container and housing such that the container remainsstationary relative to the housing.

In a preferred embodiment, the container 100 is filled with a substancewhich is dispensed therefrom in specific metered doses by depressing ormoving the valve stem 110 from an extended closed position to adepressed open position, which in turn opens the value or value system.Preferably the substance is a medicament, although it should beunderstood that the container should be used to hold a variety ofnon-medicinal substances, including, but not limited to, variousliquids, foams or aerosols. A single metered dose is dispensed from thecontainer by each reciprocal, longitudinal movement of the valve stemand attendant opening and closing of the valve.

In operation, the opening of the valve stem and valve is effected bymoving the container 100 reciprocally within the housing 10 along alongitudinal axis, defined by the valve stem and the reciprocal movementof the container, by depressing the exposed bottom end 104 of thecanister relative to the housing 10 so as to move the valve stem 110 tothe open position as it is supported within the well by the supportblock. Alternatively, an actuator can be moved to open the valve systemof the container, which can remain stationary with respect to asupporting housing, a cap and/or an indicating device mounted thereto.For example, the actuator can be attached to the end of the container inthe form of a pump device or the like.

As the valve stem is moved to the open position, the container dispensesa metered dose of the substance in aerosol form through the well andorifice and into the exhaust port. The substance in aerosol form is thentransmitted to the user through the exhaust port of the mouthpiece byway of either a self-generated or assisted airflow. Alternatively,metered doses of liquids and the like can be dispensed from thecontainer.

In other delivery systems, the housing and holder for the container areattached to a component having a chamber with an output end. Examples ofthese kinds of delivery systems are shown for example in U.S. Pat. No.5,012,803, issued May 7, 1991, and U.S. Pat. No. 4,460,412, issued Sep.11, 1984, the entire disclosures of which are hereby incorporated hereinby reference. (No license, expressed or implied, is intended to begranted to any patent by reason of the incorporation by referenceherein.) In these kinds of delivery systems, the component having thechamber can be adapted to receive the mouthpiece of the housing, or itcan be integrally connected with a holder supporting the container. Ineither embodiment, the metered dose of substance, preferably amedicament, in aerosol is first dispensed from the container into thechamber, and thereafter inhaled by the user. Other dispensing devicesare also shown in U.S. application Ser. No. 11/334,940, filed Jan. 19,2006 and entitled Dispensing Device, the entire disclosure of which ishereby incorporated herein by reference.

In a preferred embodiment, the container 100 is intended to dispense apredetermined number of metered doses of substance. For example,conventional inhaler containers typically hold on the order of 100 to200 metered doses. In operation, it is important that the user be awareof the number of metered doses remaining in the container such that theuser is not caught unaware with an empty canister when in need of thesubstance, such as a medicament. It should be understood, however, thatthe dispenser housing, with its upper and lower portions, can be usedwithout an indicating device, for example to ensure that a particularcontainer is used with a specifically suited dispenser housing.

Now referring to FIGS. 1A, 3, 29, 31 and 54A-58, the indicating device50, or indicator assembly, is disposed in the lower portion 14, 114. Theindicator assembly can take many forms, as disclosed for example andwithout limitation in U.S. Pat. Nos. 6,142,339, 6,161,724, 6,435,372 and6,561,384, the entire disclosures of which are hereby incorporatedherein by reference. The indicator assembly can include a singleindicator member, or a plurality of (i.e., more than one) indicatormembers, shown for example as three co-axially mounted indicator members56 in the various embodiments of FIGS. 54A-58. In addition, theindicator assembly can be configured as a mechanical device or anelectrical device, or a combination thereof, and can include withoutlimitation various analog and digital readouts and indicia.

Referring to FIGS. 54A-58, an actuator includes an actuator arm 70having a first end pivotally connected to a housing. A post member orplunger 72 is longitudinally moveable and engages the actuator arm at adistance from the hinge axis of the arm. In one embodiment, the postmember is connected to the actuator arm, and in one embodiment isintegrally formed therewith. The plunger is moveably supported in thehousing along an axis parallel to the longitudinal axis defined by thereciprocal movement of the container within the housing. A spring 74 isdisposed between the arm 70 and the housing. In various embodiments, thespring can be configured as a leaf spring 73 or a coil, compressionspring or a cantilever spring 71, which engages a ramped surface on thearm 70. An end portion of the actuator arm with the ramped surfaceslides along and biases or bends the resilient cantilever spring. In anyof these embodiments, the spring 74 biases the actuator arm andultimately the plunger upwardly against the top surface of the canister,or against a mounting portion secured thereto. It should be understoodthat torsion (e.g., acting at the hinge/pivot axis) and tension springs,and the like, would also work to bias the actuator member upwardly intoengagement with the container. A stop member 424 limits the upwardtravel of the actuator member. The springs can be made of metal orplastic.

In operation, the container is moved longitudinally within the housingso as to depress the valve stem to the open position and thereby openthe valve as explained above. As the container is moved downwardlywithin the housing, the actuator arm 70 is moved longitudinally downwardas it is pivoted about its hinge axis. When the container is released bythe user, the spring (not shown) within the container biases thecontainer upwardly within the housing along the longitudinal axis suchthat the valve stem 102 is moved to the closed position within thecontainer so as to close the valve, while the spring 74 biases theactuator arm upwardly. As the actuator is reciprocally moved, an end 76thereof opposite the pivot axis is configured with a ratchet arm, whichselectively engages a ratchet gear 78, which in turn operably moves oneor more the indicator members 56 upon a predetermined number ofreciprocal movements.

The indicator members 56 are provided with indicia that are visiblethrough one or more viewing windows formed in the lower portion. Theindicia indicate to the user the number of doses that remain in or havebeen dispensed from the container. In one embodiment, the indicia takethe form of a color code, where, for example, a portion of the wheel iscolored green to indicate the starting full position, a portion iscolored yellow to indicate a medium fullness and a portion is coloredred to indicate that the container is empty. Obviously, other colors,shading or alpha-numerical indicia can be provided on the indicatorwheel to indicate the relative fullness or emptiness of the container.

In one embodiment, the indicator assembly includes three indicatormembers 56 coaxially mounted on an axle and rotatable thereabout. Eachof the indicator members is configured as an indicator wheel having acircumferential skirt with an outer circumferential surface on whichindicia (shown as numbers) are applied. In this embodiment, the ratchetgear 78 is coaxially mounted with the indicator wheel. The ratchet gear78 includes a plurality of teeth formed around its periphery. In oneembodiment, the ratchet gear is integrally molded with the indicatorwheel, although it should be understood that the gear and wheel can bemade separately and thereafter attached one to the other by welding,adhesive and the like.

In one embodiment, the first indicator member includes a resilientadvancement member 58 that overlies ratchet gear teeth formed on thesecond indicator member. Likewise, the second indicator member includesan advancement member 58 that overlies ratchet gear teeth formed on thethird indicator member. It should be understood by one of skill in theart that one or more indicator members may be used to provide anindication of dosages used or available, and that the three indicatormembers shown in the Figures is meant to be illustrative, rather thanlimiting. In addition, it should be understood that a plurality ofindicator members refers to any number of indicator members greater thanone.

Referring to FIGS. 54A-58, an indicator housing 38 is shown as having apair of engagement members 62 formed integrally with the housing andincluding ramped surfaces. A plurality of non-return members 64 extendfrom the housing and selectively engage the ratchet gear(s) to ensureunidirectional rotation of the indicator member(s). Although theengagement members and non-return members are shown as being formed inor extending from a module housing, one of skill in the art shouldunderstand that those members or equivalent features could also beformed in or connected to the dispenser housing or actuator boot thatsupports the container or disposed on or connected to the containeritself.

In operation, the container is moved longitudinally within the housing10 so as to depress the valve stem 102 to the open position so as toopen the valve as explained above. As the container is reciprocallymoved within the housing, the actuator arm 70, or pawl portion 76thereof, engages the ratchet gear 78 secured to the first indicatormember and rotates the first indicator member a predetermined angular orincremented amount corresponding to the pitch of the teeth disposedaround the periphery of the ratchet gear. A stop member 424 is disposedover the pawl portion 76 so as to limit the rebound of the actuator arm70.

The reciprocal movement of the container relative to the housing isrepeated until the first indicator member 56, and its ratchet gear 78,are rotated one complete revolution. The predetermined number ofreciprocal movements required to advance the first indicator member onerevolution is equal to the number of teeth disposed about the peripheryof the ratchet gear 78. As the first indicator member is rotated bysuccessive movements of the container relative to the housing, theadvancement member 58 of the first indicator member is brought intoselective engagement with the engagement member 62, configured with theramped surface formed in the housing. In particular, the engagementmember 62 biases a tooth portion of the advancement member 58 intoengagement with one of the teeth of the ratchet gear 78 on the secondindicator member.

As the first indicator member is further rotated by successive movementsof the container relative to the housing, whether it be the dispenserhousing for the container or the module housing described below, theadvancement member 58 engages one of the teeth on the ratchet gear 78 ofthe adjacent (i.e., second) indicator member and advances the indicatormember a predetermined incremental angular amount corresponding to thepitch of the ratchet gear teeth. The term incremental is meant to referto the angular amount the indicator member is moved by the advancementof one actuation, which corresponds to the movement of one tooth,regardless of whether the indicating device is indicating the number ofdoses left (e.g., counting down) or indicating the number of dosesadministered (e.g., counting up).

As the resilient advancement member 58 clears the engagement member 62,it springs away from the ratchet gear such that further advancements ofthe first indicator member do not effect a rotation of the secondindicator member until the first indicator member completes yet anothercycle so as to again bring the advancement member into engagement withthe next tooth of the second indicator member ratchet gear, and so on.The second indicator member with its advancement member 58 similarlyinteracts with a second engagement member 62 overlying ratchet teeth ofthe third indicator member so as to selectively engage and advance thethird indicator member a predetermined incremental amount for eachcomplete rotation of the second indicator member. It should beunderstood that more indicator members could be similarly assembled toprovide an incremental indicating device.

A secondary or warning indicator member 110 is rotatably supported inthe dispenser housing adjacent the indicator members about an axisparallel to and spaced apart from the axis of the indicator members 56.The warning indicator 110 has an outer circumferential surface withwarning dosage indicia applied thereto. Preferably, the warning dosageindicia takes the form of a color coding, for example a portion or zoneof the surface is green, while another portion or zone is red.Preferably a plurality of zones is used, for example and withoutlimitation two zones of green and red respectively, or three zones ofgreen, yellow and red. Alternatively, alphanumeric characters, textmessages etc. as herein described can be used as indicia. It should beunderstood that a surface of the indicator member perpendicular to theaxis of rotation also can be configured with the indicia. The surface ofthe indicator member is visible through a viewing window formed in thelower portion of the dispenser housing.

The second indicator member 110 further includes at least one drivenmember 306, and preferably a plurality of driven members, configured inone embodiment as a teeth extending radially outward from the secondindicator member on one side of the circumferential indicia surface.Taking into account the spacing between the axes of rotation for theprimary indicator members 56 and the secondary indicator member 110, adrive member coupled to one of the indicator members and the drivenmembers are configured and have sufficient lengths so as to mesh after apredetermined number of rotations of the first indicator member 56configured with the drive member. The second indicator member 110 isalso provided with a plurality of ratchet teeth formed circumferentiallyaround the axis of rotation on the side of the indicator member oppositethe drive member. A non-return member extends from the dispenser housingor module housing and successively, selectively engages one or more ofthe ratchet teeth so as to allow the second indicator member 110 torotate in only one direction. Various embodiments incorporating awarning indicator are further disclosed in U.S. patent application Ser.No. 10/968,815, filed Oct. 18, 2004 and entitled Indicating Device WithWarning Dosage Indicator, the entire disclosure of which is herebyincorporated herein by reference.

In a preferred embodiment of the dispenser, the indicator assembly isarranged in an indicator module. The indicator module is shaped to bereceived within the lower portion 14, 114 of the dispenser housing whereit is disposed around a portion of the support block 18. In particular,the support block is spaced apart from the wall of the dispenserhousing, otherwise referred to as the actuator boot, so as to form adonut-shaped socket in the bottom of the housing. The module includes amodule housing 60 having an inner concave surface that is shaped to matewith an outer convex surface of the cylindrical support block and anouter convex surface that is shaped to mate with the inner concavesurface of the housing which is also generally cylindrical. In this way,the module housing is shaped to be received within the socket formedaround the support block. Preferably, the module housing has asemicircular shape and fits around a portion of the support blockopposite the orifice opening so as to not interfere with the dispensingof the medicament, or the airflow transmitting the medicament to thepatient. In this way, the module is maintained rearwardly of themidpoint of the support block. One of skill in the art shouldunderstand, however, that the module, or module housing, can beconfigured in any number of different sizes and shapes so as to beaccommodated in a variety of housings or cap assemblies, with or withoutsupport blocks and the like. The module housing can be made of a singlepiece, or from two or more pieces joined to form the housing.

It should be understood, however, that the module can be secured withinthe housing by any number of conventional means, including the use offasteners or adhesive. Alternatively, the module can simply be press fitinto the socket formed between the support block and housing wall. Inone embodiment, the module is inserted through an opening 420 in thelower portion, wherein a face member 422 of the housing is secured tothe lower portion, for example with a snap fit, adhesive, friction fit,or other known connection devices. The post member 72 can thereafter beconnected to the actuator arm 70

In various embodiments, as explained above, the indicia are applied to acircumferential surface of the indicator wheel, for example in the formof numbers ranging from 0 to 9, with the ratchet gear on the indicatormember having 10 teeth. In operation, it should be understood that thethree, or more or less, indicator members can be preset to the maximumnumber of dosages contained within the container, with the indicia, orin this case numbers, arranged about the periphery of the indicatorwheel, such that successive, sequential actuations of the containercause the indicator members to count down.

Alternatively, the indicator members are assembled such that the zero(0) of each indicator member is displayed in the viewing window to theuser. The container is then actuated by the user such that the firstindicator member rotates within the housing to sequentially display thenumber of doses that have been dispensed from 1 to 9. Upon the tenthactuation, the indicator member completes a single revolution, by virtueof the ten teeth preferably formed about the ratchet gear whichcorrespond to the predetermined number of actuations, and causes thesecond indicator member to advance one number from 0 to 1 as the firstindicator member again displays a 0 such that the two members togetherindicate that 10 dosages have been dispensed. The first indicator memberis again rotated by successive actuations until another single rotationis completed to further rotate the second indicator to reveal the 2, soas to indicate that 20 dosages have been dispensed. Upon a completerotation of the second indicator member, corresponding to 100actuations, the third indicator member is advanced to reveal a 1 in theviewing window with the first and second indicator members revealing a0, and so on.

Although the indicator assembly embodiments of FIGS. 54A-58, forexample, are shown as being mounted in the indicator module, one ofskill in the art should understand that the assembly, including theaxle, indicator members, ratchet gears, actuator member and spring couldbe mounted directly in the dispenser housing or actuator boot thatsupports the container. Similarly, the engagement member, or members,and non-return member, or members, could be formed in the dispenserhousing that supports the container, otherwise referred to as theactuator boot.

Although the present invention has been described with reference topreferred embodiments, those skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention. As such, it is intended that the foregoingdetailed description be regarded as illustrative rather than limitingand that it is the appended claims, including all equivalents thereof,which are intended to define the scope of the invention.

1-36. (canceled)
 37. A dispenser for use with a container for dispensingdosages of a substance from the container, the dispenser comprising: adispenser housing comprising: a lower portion having a support block; atubular upper portion connected to the lower portion and defining acavity shaped to receive the container, said tubular upper portionhaving an outer surface; a tubular housing circumferentially surroundingsaid outer surface of at least a portion of said tubular upper portion,wherein said tubular housing is connected to said dispenser housing; andan indicating device separate from said tubular housing and connected tosaid dispenser housing.
 38. The dispenser of claim 37 wherein saidindicating device is disposed interiorly in said dispenser housing. 39.The dispenser of claim 38 wherein said indicating device is disposed insaid lower portion of said dispenser housing adjacent said supportblock.
 40. The dispenser of claim 37 wherein said tubular housingcircumferentially surrounds an outer surface of at least a portion ofsaid lower portion.
 41. The dispenser of claim 37 wherein said tubularhousing is moveable relative to said dispenser housing from a lockedconfiguration to an unlocked configuration.
 42. The dispenser of claim41 wherein said upper and lower portions are non-moveably connected whensaid tubular housing is in said locked configuration, and wherein saidupper and lower portions are moveably connected when said tubularhousing is in said unlocked configuration.
 43. The dispenser of claim 42wherein said tubular housing comprises a first slot and said upperportion comprises a second slot aligned with said first slot, andfurther comprising a retainer having a follower moveable in said firstand second slots, wherein said retainer is adapted to be coupled to andin direct contact with said container.
 44. The dispenser of claim 43wherein at least a portion of said first slot is ramped along alongitudinal direction.
 45. The dispenser of claim 43, wherein saidretainer is moveably connected to said upper portion.
 46. The dispenserof claim 45 wherein said retainer comprises a retainer ring adapted tobe disposed around a portion of said container and an engaging portionextending from said retainer ring and moveably engaging said upperportion.
 47. The dispenser of claim 37, wherein said tubular housingcomprises an enlarged portion formed on one side thereof.
 48. Thedispenser of claim 37 wherein said indicating device comprises anindicator comprising dosage indicia.
 49. The dispenser of claim 37further comprising said container disposed in cavity.
 50. The dispenserof claim 49 wherein said container is moveable relative to said upperportion and said tubular housing.
 51. The dispenser of claim 49 wheresaid container holds a medicament.
 52. The dispenser of claim 37,wherein said lower portion and said upper portion are pivotallyconnected and moveable about a pivot axis.
 53. A dispenser fordispensing dosages of a substance, the dispenser comprising: a dispenserhousing comprising: a lower portion having a support block; a tubularupper portion connected to the lower portion and defining a cavityshaped to receive the container, said tubular upper portion having anouter surface; a tubular housing circumferentially surrounding saidouter surface of at least a portion of said tubular upper portion,wherein said tubular housing is connected to said dispenser housing; anindicating device separate from said tubular housing and connected tosaid dispenser housing; and a container disposed in said cavity andhaving an end portion comprising a valve stem disposed in said supportblock.
 54. The dispenser of claim 53 wherein said indicating device isdisposed interiorly in said dispenser housing.
 55. The dispenser ofclaim 54 wherein said indicating device is disposed in said lowerportion of said dispenser housing adjacent said support block.
 56. Thedispenser of claim 53 wherein said tubular housing circumferentiallysurrounds an outer surface of at least a portion of said lower portion.57. The dispenser of claim 53 wherein said tubular housing is moveablerelative to said dispenser housing from a locked configuration to anunlocked configuration.
 58. The dispenser of claim 57 wherein said upperand lower portions are non-moveably connected when said tubular housingis in said locked configuration, and wherein said upper and lowerportions are moveably connected when said tubular housing is in saidunlocked configuration.
 59. The dispenser of claim 53, wherein saidtubular housing comprises an enlarged portion formed on one sidethereof.
 60. The dispenser of claim 53 wherein said indicating devicecomprises an indicator comprising dosage indicia.
 61. The dispenser ofclaim 53 wherein said container is moveable relative to said upperportion and said tubular housing.
 62. The dispenser of claim 53 wheresaid container holds a medicament.